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Endotronix Receives FDA Premarket Approval of the Cordella™ PA Sensor System for the Treatment of Heart Failure

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Cordella, which consists of the now PMA-approved Cordella PA Sensor and commercial Cordella™ HF System, enables comprehensive heart failure management in the home using pulmonary artery (PA) pressure, a leading indicator of congestion, and non-invasive vital sign data to improve care decisions.Backed by definitive clinical evidence from the PROACTIVE-HF pivotal trial, the company is planning a U.S. launch of Cordella this year.

NAPERVILLE, Ill., June 24, 2024 /PRNewswire/ — Endotronix, Inc., a privately held company dedicated to advancing the treatment of heart failure (HF) at the intersection of digital health and medtech, today announced Premarket Approval (PMA) from the U.S Food and Drug Administration (FDA) of the company’s Cordella™ Pulmonary Artery (PA) Sensor System for the treatment of New York Heart Failure (NYHA) class III heart failure patients. The Cordella platform is the first and only PA pressure-guided platform to offer comprehensive patient management using daily PA pressure and vital signs from home to guide therapeutic management and improve patient outcomes.

“This approval is very exciting and has the potential to transform care for HF patients. Endotronix’s solution provides a more complete clinical picture of the patient, so providers are able to make informed remote care decisions between office visits,” stated Dr. Liviu Klein, Section Chief of Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension, and Heart Transplant at the University of California San Francisco and national principal investigator of the PROACTIVE-HF trial. “PROACTIVE-HF demonstrated that with Cordella clinicians achieved more optimal and timely dosing of key HF medications, significantly improving outcomes. In addition, the easy-to-use platform engages patients to drive consistent daily habits and self-awareness of trends to support sustainable lifestyle changes.”

Cordella is a proactive HF management platform that delivers daily PA pressure and other vital data via an implantable sensor and user-friendly, non-invasive health tools, respectively, to a managing HF clinician for remote patient care. This information guides clinical decision-making and medication dosing while enhancing the adoption of guideline-directed medical therapy (GDMT) to reduce congestion and improve outcomes. Regulatory approval was based on the PROACTIVE-HF trial, which demonstrated a markedly low 0.159 rate of heart failure hospitalization and all-cause mortality at 6 months.

In addition, Cordella enables:

Seated PA pressure measurements, preferred by most patients, with a handheld reader.Patient visibility into key health trends to support healthy lifestyle changes.Secure messaging on a tablet between the clinical team, patient, and caregiver to support remote care.Reimbursement for implantation and ongoing management through existing reimbursement pathways.

“At Endotronix, we firmly believe that innovation can drive patient care excellence in the home and ultimately change outcomes for patients with heart failure, one of the largest cost categories in healthcare. The FDA’s approval validates this foundational belief and is a major milestone for our company and the field of HF management,” commented Harry Rowland, CEO and co-founder of Endotronix. “With this approval, we will deliver proactive, comprehensive care that extends optimal HF therapeutic management to more patients, keeping them out of the hospital and living more fulfilling lives.”

Endotronix will launch Cordella in the U.S. later this year. The company also shared that they have submitted a dossier for CE Mark review and expect a decision on European market access in 2025.

About Endotronix
Endotronix innovates at the intersection of medtech and digital health to improve care for people living with heart failure (HF). The comprehensive Cordella solution enables proactive, data-driven HF management that engages patients, reduces and prevents congestion, and improves outcomes. The Cordella Sensor is an implantable pulmonary artery (PA) pressure sensor that directly measures the leading indicator of congestion, allowing early, targeted therapy. The Cordella HF System is a patient health management platform, which combines comprehensive vital sign data from non-invasive devices to support patient-clinician engagement and care decisions. Combining trended insights, the versatile and scalable Cordella enhances current clinical practice and supports guideline-based care across the entire HF continuum. Learn more at www.endotronix.com.

In the U.S., the Cordella PA Sensor System is Rx Only. CAUTION: Federal law restricts this device to sale by or on the order of a physician.
In Europe, the Cordella PA Sensor System is Exclusively for Clinical Investigation.
The Cordella HF System is commercially available in the U.S. and Europe.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain predictions, estimates, or other information that might be considered forward-looking statements. Such forward-looking statements are not a guarantee of future performance.

 

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View original content:https://www.prnewswire.co.uk/news-releases/endotronix-receives-fda-premarket-approval-of-the-cordella-pa-sensor-system-for-the-treatment-of-heart-failure-302179604.html

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RefrigiWear® Unveils New Heated PPE System at ASSP Safety26 Expo

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ANAHEIM, Calif., June 15, 2026 /PRNewswire/ — RefrigiWear®, the leading manufacturer of insulated PPE and workwear for the global cold chain, announced the new ThermaSync™ Jacket and ThermaSync™ Glove, an integrated heated workwear system designed to keep workers warm, productive and protected even in temperatures down to -15°F.

ThermaSync™ combines heating technology with a completely unique connection to deliver warmth from core to fingertips.

The new products will debut at the ASSP Safety26 Conference & Expo, June 15–17, in Anaheim, California.

Connected Warmth from Core to Fingertips

ThermaSync™ combines battery-powered heating technology with industrial-grade durability and a completely unique connection between the products to deliver synchronized warmth from core to fingertips.

“Cold environments create real challenges for workers, affecting comfort, dexterity, productivity and job performance. Worn together, ThermaSync™ products create a connected system that maintains consistent warmth across the body and hands,” says RefrigiWear CEO Ryan Silberman.

The result is an innovative solution for insulated PPE that helps workers stay safe, comfortable and focused on the job.

ThermaSync™ Jacket

Even before powering up, the ThermaSync™ Jacket is insulated for protection in temperatures down to -15°F. Heating elements across the chest and back, plus high- and low-heat settings, let workers adjust warmth as activity levels or conditions change.

The jacket features durable abrasion-resistant, water-resistant materials, multiple pockets and an adjustable hem to block cold drafts, along with one rechargeable lithium-ion battery pack that provides up to 8 hours of heat per charge.

ThermaSync™ Glove

Also insulated for -15°F temperatures, the ThermaSync™ Glove uses magnetic connectors to draw power from the ThermaSync™ Jacket, delivering extra warmth across the back of the hand and fingers. This unique connector amplifies cold protection to your hands because if your hands are cold, it is hard to focus on anything else.

A waterproof design and grip-enhancing synthetic leather palm support secure material handling. Touchscreen-capable thumb, index and middle fingers let workers use screens without exposing hands to cold temperatures.

Experience ThermaSync™ at Safety26

ASSP Safety26 attendees are invited to visit RefrigiWear Booth #4415 for demonstrations of the ThermaSync™ Jacket and ThermaSync™ Glove.

About RefrigiWear

Founded in 1954 by Myron Breakstone, RefrigiWear makes the toughest workwear for the toughest workers and for the coldest conditions. With a long history rooted in real-world experience, RefrigiWear understands the challenges of working in extreme cold, helping the company deliver high-quality insulated workwear that stands up to the coldest, dirtiest, harshest conditions imaginable. Learn more at RefrigiWear.com.

View original content to download multimedia:https://www.prnewswire.com/news-releases/refrigiwear-unveils-new-heated-ppe-system-at-assp-safety26-expo-302800795.html

SOURCE REFRIGIWEAR

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PSignite, the company behind the CPGvision platform, is recognized by The Silicon Review as one of the Most Reputable Companies of the Year 2026

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NEW YORK, June 15, 2026 /PRNewswire/ — PSignite, a leading provider of innovative software solutions in the trade and revenue management space, today announced that it has received The Silicon Review’s Most Reputable Companies of the Year 2026 award. Click the link below for the interview with PSignite CEO, Jon Flaherty.

https://thesiliconreview.com/magazine/profile/why-tpm-and-rgm-success-depends-on-adoption-not-just-software 

About PSignite

PSignite is a leading provider of advanced software solutions for the consumer packaged goods industry. With a focus on utilizing artificial intelligence and machine learning to help companies optimize their trade promotion funds and grow revenue profitably, PSignite offers innovative platforms designed to streamline processes and deliver actionable insights. For more information, visit cpgvision.com.

View original content to download multimedia:https://www.prnewswire.com/news-releases/psignite-the-company-behind-the-cpgvision-platform-is-recognized-by-the-silicon-review-as-one-of-the-most-reputable-companies-of-the-year-2026-302800802.html

SOURCE PSignite

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GateKeeper to Showcase Proximity-Based Identity Access for Shared Workstations at Identiverse 2026

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GateKeeper will showcase its proximity-based passwordless MFA and identity access platform at Identiverse 2026 at Booth #113, highlighting how it helps mission-critical industries secure shared workstations without slowing down frontline workflows. The press release positions GateKeeper as a solution for improving identity assurance, user accountability, audit visibility, and frictionless access across manufacturing, healthcare, law enforcement, and other high-security environments.

LAS VEGAS, June 15, 2026 /PRNewswire-PRWeb/ — Untethered Labs, Inc., creator of GateKeeper Proximity, today announces that it will showcase GateKeeper Proximity and GateKeeper IDP at Identiverse 2026, taking place June 15–17 at Mandalay Bay in Las Vegas. Attendees can visit GateKeeper at Booth #113 for live demonstrations focused on passwordless workstation access, shared workstation accountability, and stronger identity assurance for mission-critical environments.

” At Identiverse, we are showing how GateKeeper extends passwordless MFA and identity assurance to the frontline environments where speed, accountability, and security all have to work together.” Siddharth Pothbare.

GateKeeper is addressing a persistent identity challenge for organizations where shared workstations, fast user switching, operational uptime, and auditability all matter. While many organizations have invested in cloud SSO, MFA, and identity governance, shared endpoint environments remain difficult to secure without adding friction to daily workflows.

Manufacturing floors, healthcare clinics, law enforcement facilities, and other high-throughput operations often require multiple users to access the same endpoint throughout the day. In these environments, long passwords, shared credentials, frequent password resets, and incomplete user traceability can create both security risk and productivity drag. GateKeeper helps organizations reduce reliance on passwords while tying workstation access events back to the individual user.

GateKeeper combines proximity-based authentication with centralized access management and identity provider capabilities. Users can authenticate with a GateKeeper token, supported NFC/RFID badge, or mobile credential, helping organizations enforce consistent MFA while maintaining a fast and familiar user experience. The result is stronger identity assurance from the workstation to applications, without forcing frontline teams into slower or more disruptive login processes.

“Identity programs have made major progress in the cloud, but shared workstations remain one of the hardest environments to secure without disrupting operations,” said Siddharth Pothbare, CEO at Untethered Labs. “At Identiverse, we are showing how GateKeeper extends passwordless MFA and identity assurance to the frontline environments where speed, accountability, and security all have to work together.”

At Booth #113, GateKeeper will demonstrate how organizations can:

Replace shared passwords with token, badge, or mobile-based passwordless authentication.Tie workstation access events to individual users, even in shared workstation environments.Enforce phone-free MFA consistently across mission-critical endpoints and applications.Improve workflow speed for operators, clinicians, officers, and frontline staff.Generate clean audit logs that support compliance, investigations, and access reviews.Extend identity assurance from workstation login to downstream application access through GateKeeper IDP capabilities.

GateKeeper’s approach has already helped mission-critical organizations reduce login friction while improving security and accountability. In one customer deployment, Major Tool & Machine reported significant time savings compared to conventional authentication methods.

“While conventional two-factor authentication methods could have cost the company over 240 hours of login time for 14,000 logins in one month, GateKeeper took only 20 hours of time to log in. GateKeeper made the computers secure, and cost 90% less in time as compared to any other authentication method.” — Tom Riddle, Network Administrator, Major Tool & Machine

About Untethered Labs, Inc.

Untethered Labs, Inc. is the creator of GateKeeper Proximity (https://gkaccess.com) a passwordless authentication and access management platform designed for environments where security, speed, and accountability are critical. GateKeeper helps organizations secure workstation access, enforce MFA, streamline user authentication, and maintain audit visibility across shared and dedicated endpoint environments.

Media Contact

GateKeeper Proximity, Untethered Labs, Inc., 1 2405475446, info@gkaccess.com, www.gkaccess.com 

Twitter, LinkedIn

View original content to download multimedia:https://www.prweb.com/releases/gatekeeper-to-showcase-proximity-based-identity-access-for-shared-workstations-at-identiverse-2026-302799979.html

SOURCE Untethered Labs, Inc.

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